Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00483743
First received: May 23, 2007
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.


Condition Intervention Phase
Copd Bronchitis
Drug: TPI 1020
Drug: Budesonide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sputum neutrophil counts on Days 0 and 21. • Trough FEV1, SVC and IC on Days 0, 21 and on Day 42. • eNO levels on Days 0, 21 and on Day 42. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPI 1020
TPI 1020 500 mcg BID x 42 days
Drug: TPI 1020
250 mcg/caps 2 caps BID x 42 days
Active Comparator: Budosenide cortico
Budesonide 800 mcg BID x 42 days
Drug: Budesonide
400mcg mcg capsules- 2 capsules BID
Placebo Comparator: Placebo
Placebo inhaler
Drug: Placebo
2 caps BID x42 days

Detailed Description:

A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
  • Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD

Exclusion Criteria:

  • COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
  • Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483743

Locations
Canada, Alberta
University of alberta Hsopital
Edmonton, Alberta, Canada, T6G2B7
Canada, British Columbia
Vancouver Hospital Lung Center
Vancouver, British Columbia, Canada, V5Z 1 M9
Canada, Ontario
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N4A6
Canada, Quebec
Clinique Medical Les Saules
Les Saules, Quebec, Canada, G1P 1J6
Omnispec Clinical Research Inc.
Mirabel, Quebec, Canada, J7J 2K8
Hopital Thoracique Montreal-CSUM
Montreal, Quebec, Canada, H2X2P4
Hopital Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Kells Medical Research Group
Pointe-Claire, Quebec, Canada, H9R 4S3
Diex Research Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
CHUS -Hopital FLEURIMONT
Sherbrooke, Quebec, Canada, J1H5N4
Complexe Medicale Langelier
St-Leonard, Quebec, Canada, H1S 3A9
Centre de Cardiologie et de Pneumologie de l'Université Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: Francois Maltais, MD Centre de Cardiologie et de Pneumologie de l'Université Laval
Study Director: Rene Pageau, M.Sc Pharm Pharmaxis
  More Information

No publications provided

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00483743     History of Changes
Other Study ID Numbers: TPI 1020-203
Study First Received: May 23, 2007
Last Updated: November 30, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bronchitis
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014